Histogen Update - Spencer Kobren Speaks With Dr. Craig L. Ziering

[tizzle]

by the way:

It looks like "Society for Investigative Dermatology (SID) Annual Meeting" is starting today in which Dr. Naughton is to present "Stimulation of hair growth in humans by cell-secreted proteins"

maybe there will be some new information in a few days/weeks

[Pate]

see below


ABSTRACT FINAL ID: 519
TITLE: Stimulation of hair growth in humans by cell-secreted proteins
AUTHORS (FIRST NAME INITIAL LAST NAME): G. K. Naughton1, C. Ziering2, N. Sadick3, D. Perez-Meza4, M. Hubka1, D. Ehrlich1, J. Mansbridge1
INSTITUTIONS (ALL): 1. Histogen, San Diego, CA, United States.
2. Ziering Medical, Los Angeles, CA, United States.
3. Sadick Dermatology, New York, NY, United States.
4. Permanent Hair Solutions, Maitland, FL, United States.
ABSTRACT BODY: We have evaluated a bioengineered human cell-derived formulation, termed Hair Stimulating Complex (HSC), on the effects of hair growth activity in male pattern baldness and female diffuse hair loss. HSC is produced by cells grown on beads in hypoxic bioreactors and contains cytokines including KGF,VEGF,follistatin and noggin. Follistatin and noggin antagonize activin and BMPs which maintain the quiescent state of hair follicle stem cell proliferation. We hypothesized that injection of this medium may increase the supply of progenitor and transit amplifying keratinocytes to the hair shaft, leading to an increase in the thickness of the hairs and a reversal of the miniaturization process. Three clinical studies have been performed. The pilot study was a double-blind, randomized, placebo-controlled trial involving 26 men with androgenetic alopecia. At baseline one area of the scalp received (4) 0.1cc intradermal injections (injs) of HSC and the parallel site received identical injs of placebo. HSC showed an excellent safety profile and a statistically significant increase in hair shaft thickness (p<0.05) at 3 months and hair density at 3 months (p <0.03) and 1 year (p<0.03) as assessed by Trichoscan image analysis. Analysis of the distribution of hair density at 1 year showed that the effect was no longer localized to 2-3mm around the injection site, as was the case at 12 weeks. Increased terminal hairs were seen in the entire region within the 4 injection sites supporting the hypothesis that HSC stimulated resting and miniaturizing follicles to increase terminal hair growth. A Phase I/II 55 patient trial with an identical protocol but with 8 injs of HSC and control at baseline and a repeat dose at week 6 has completed enrollment. A 10 patient non-controlled study for men and women with hair loss is being conducted, with patients receiving 20 injs of HSC at baseline and week 6. The efficacy results seen with HSC represent a novel regenerative medicine approach in hair growth treatment.

KEYWORDS: Hair, Clinical trials, Biologic therapy.
CURRENT 1ST PREFERRED CATEGORY: Human Clinical Research and Therapeutics
CONTACT (E-MAIL ONLY): ebrandt@histogeninc.com
SESSION LOCATION: Ballroom B/C
SESSION DAY & DATE: Thursday, May 10, 2012
SESSION START TIME: 10:00 AM

Couple of bits of new, interesting info in there.

1. "Analysis of the distribution of hair density at 1 year showed that the effect was no longer localized to 2-3mm around the injection site, as was the case at 12 weeks."

To my knowledge this has never been mentioned before. Both good and potentially a little bit bad news. Good because obviously this has proved it's not just a localised effect requiring injections 4mm apart and that it appears to spread out slowly over time. But slightly worrying because the 2mm effect was a good way to ensure we didn't end up growing hair halfway down on foreheads!

But I don't think it's too bad because it's really starting to look like HSC just reactivates the dormant follicles. So its effect on areas that never had terminal follicles should be minimal. At worst it might require the odd laser hair removal of stray hairs growing outside the hairline. Hopefully!

2. "A 10 patient non-controlled study for men and women with hair loss is being conducted, with patients receiving 20 injs of HSC at baseline and week 6."

This is new. They haven't mentioned this before. There is no placebo so it's not blinded but it sounds like these injections have actually already happened... which brings me to #3.

3. "A Phase I/II 55 patient trial with an identical protocol but with 8 injs of HSC and control at baseline and a repeat dose at week 6 has completed enrollment."

Completed enrollment?! I am hoping that doesn't mean they haven't done the injections yet. Last we heard (December I think) they were supposed to have done the first set of injections in January 2012. However it does say "Three clinical studies have been performed" so hopefully that means it's just poor wording in the abstract. We'll find out soon.


Anyway, to those asking if we're all back on the Histogen bandwagon now... some of us never left! I've been saying HSC and CB-03-01 are our best chance til the cows come home. Problem is, there is so much crap on these forums that it's hard to keep track of.

For the record the HSC regrowth at 12 months was as high as 120% increase in terminal hair in one patient, from a pretty strong base count. It doesn't actually say how many new terminal hairs that translates to but I might be able to work it out with some math from the percentages they gave. I'll have a go.

They did say that average regrowth at 12 months was 25 hairs per injection. I think in most cases that would be about a 15% increase in total hair count.

[UK_]

Since when did this become a thread about Finasteride?

------

Nice post Pate - im looking forward to hearing from Histogen again, it's been a while.

[Davey Jones]

But I don't think it's too bad because it's really starting to look like HSC just reactivates the dormant follicles. So its effect on areas that never had terminal follicles should be minimal. At worst it might require the odd laser hair removal of stray hairs growing outside the hairline. Hopefully!

I eagerly await the day when my problem is too much hair.

[BoSox]

I've been on Fin since 2007. The only side effect I've had was a bad marriage, other than that all is well :P

120%? Histogen? I thought it was 73% regrowth, unless I'm missing something.

[2020]

They did say that average regrowth at 12 months was 25 hairs per injection. I think in most cases that would be about a 15&#37; increase in total hair count.

15% after 12 months? Where are you getting this? Even after 3 months, the hair count jumped 20%+ on average.
That 73% was the maximum result they were able to achieve at 12 months with a small injection.

Things are looking good with Histogen. As long as this stuff doesn't grow tumors at high doses, we're good

[tizzle]

we should stop throwing all these numbers. its confusing
i think we should wait until this second study is over

[neversaynever]

I think the numbers and info are a bit too vague at this point. Sure, max 73&#37; increase, but in one patient, in an area that had plenty of hairs already.

The bigger issue are areas of scalps with invisible hairs.

Im also curious of what they think about Dr Cots prostaglandin D synthase finding.

"The inhibition of hair growth is triggered when the protein binds to a receptor on the cells of hair follicles, said Prof Cotsarelis"

Personally, I believe that is the most specific info we've had for a long time. I wonder how HSC deals with that....

Besides, havent they only elapsed 3 months of 2 years? Phase 2 is two years right? And then phase 3 is 2 years....no?

Correct me if im wrong, which i hope is the case

[jpm]

If anyone knows what Histogen says at this conference that is currently going on, can they please post

Thanks

[Pate]

15% after 12 months? Where are you getting this? Even after 3 months, the hair count jumped 20%+ on average.
That 73% was the maximum result they were able to achieve at 12 months with a small injection.

Things are looking good with Histogen. As long as this stuff doesn't grow tumors at high doses, we're good

No, 20% was the increase in terminal hair count, which has always been higher than the increase in total hair. The chart on the website, which appears to show the average of the trials, has a 15% increase in total hair count at 12 months.

And no, 123% was the maximum increase in terminal hair achieved at 12 months. The 73% figure was their second best.

25 hairs per sq

[Kiwi]

I think the numbers and info are a bit too vague at this point. Sure, max 73% increase, but in one patient, in an area that had plenty of hairs already.

The bigger issue are areas of scalps with invisible hairs.

Im also curious of what they think about Dr Cots prostaglandin D synthase finding.

"The inhibition of hair growth is triggered when the protein binds to a receptor on the cells of hair follicles, said Prof Cotsarelis"

Personally, I believe that is the most specific info we've had for a long time. I wonder how HSC deals with that....

Besides, havent they only elapsed 3 months of 2 years? Phase 2 is two years right? And then phase 3 is 2 years....no?

Correct me if im wrong, which i hope is the case

I'd rather vague from Histogen over shite from RepliCel :P

[Kiwi]

If anyone knows what Histogen says at this conference that is currently going on, can they please post

Thanks

Whats the link to the conference site?

[Pate]

Okay, so. In order to stop these figures flying back and forth all over BTT and the other forums... I have bought the Histogen paper published in the JDD and linked to on their website. Cost 15 USD for a one-time purchase. Unfortunately I am not a student any more I would have free access to journals like these through my university but oh well, 15 USD is a small price to pay.

So here are the official figures from Histogen, published in the peer-reviewed journal.

At 3 months:

Shaft thickness +6%
Thickness density +13%
Terminal hair count +21%
No mention of total hair count, presumably it was not statistically significant

At 5 months:

No statistically significant increase over 3 months (obviously some individuals had better results at 5 months but the overall change was not statistically significant).

At 12 months:
Total hair count +16%
Thickness density +18%
Terminal hair count +30%

So there you have it, straight from the source. A single injection of HSC resulted in an average 30% increase in terminal hair count at 12 months. There is some other interesting stuff in the paper too but I haven't read it all yet.

[Kiwi]

Okay, so. In order to stop these figures flying back and forth all over BTT and the other forums... I have bought the Histogen paper published in the JDD and linked to on their website. Cost 15 USD for a one-time purchase. Unfortunately I am not a student any more I would have free access to journals like these through my university but oh well, 15 USD is a small price to pay.

So here are the official figures from Histogen, published in the peer-reviewed journal.

At 3 months:

Shaft thickness +6%
Thickness density +13%
Terminal hair count +21%
No mention of total hair count, presumably it was not statistically significant

At 5 months:

No statistically significant increase over 3 months (obviously some individuals had better results at 5 months but the overall change was not statistically significant).

At 12 months:
Total hair count +16%
Thickness density +18%
Terminal hair count +30%

So there you have it, straight from the source. A single injection of HSC resulted in an average 30% increase in terminal hair count at 12 months. There is some other interesting stuff in the paper too but I haven't read it all yet.

Nice find. Can't wait for their next update!!

[kaandereli]

Okay, so. In order to stop these figures flying back and forth all over BTT and the other forums... I have bought the Histogen paper published in the JDD and linked to on their website. Cost 15 USD for a one-time purchase. Unfortunately I am not a student any more I would have free access to journals like these through my university but oh well, 15 USD is a small price to pay.

So here are the official figures from Histogen, published in the peer-reviewed journal.

At 3 months:

Shaft thickness +6%
Thickness density +13%
Terminal hair count +21%
No mention of total hair count, presumably it was not statistically significant

At 5 months:

No statistically significant increase over 3 months (obviously some individuals had better results at 5 months but the overall change was not statistically significant).

At 12 months:
Total hair count +16%
Thickness density +18%
Terminal hair count +30%

So there you have it, straight from the source. A single injection of HSC resulted in an average 30% increase in terminal hair count at 12 months. There is some other interesting stuff in the paper too but I haven't read it all yet.

it takes 1 year for significant results to grow hair , which is the reason why replicel's 6 months results perceived as failure , probably they will also get good results after 6 months
but histogen is far ahead , 30% is excellent , hope they offer it soon